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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K870537
Device Name MODEL MICRO ST AMBULATORY ECG MONITOR
Applicant
ADVANCED MEDICAL PRODUCTS, INC.
FIVE ADLER DR.
E. SYRACUSE,  NY  13057
Applicant Contact JAMES H BROWN
Correspondent
ADVANCED MEDICAL PRODUCTS, INC.
FIVE ADLER DR.
E. SYRACUSE,  NY  13057
Correspondent Contact JAMES H BROWN
Regulation Number870.2800
Classification Product Code
DSH  
Date Received02/09/1987
Decision Date 04/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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